Craniosacral Therapy in Migraine Feasibility Study

描述(申请人提供)：尽管有许多新的药物疗法，偏头痛的治疗在今天仍然是一个主要的健康问题。有限的临床经验表明，头枕治疗(CST)对包括偏头痛在内的头痛可能是有效的。这项建议的主要目的是收集有关CST作为偏头痛患者常规治疗辅助手段的有效性的高质量初步数据，并确定CST在偏头痛患者中进行更大规模随机临床试验的可行性。颅骨治疗师使用一种温和触诊头部、颈部和脊柱的技术，以释放颅骨和脊柱周围组织中的限制，这些组织被认为是导致包括头痛在内的各种健康问题的原因之一。据估计，每年有200多万人次就诊于CST从业者，其中10%以上的就诊是因为头痛。目前还没有严格的研究来检验CST对偏头痛患者的有效性，尽管印象中有有益的效果。我们有限的初步数据显示，在一小部分偏头痛患者中，CST具有显著的、持续的益处。第一个具体目标是确定开发一项临床试验的可行性，比较颅骶疗法和低强度静态磁铁(注意力控制补充疗法)作为预防偏头痛治疗的可行性。偏头痛患者，有或没有先兆，将在神经科医生的护理下进行研究。在8周的基准期后，他们将被随机分为两组：1)常规医疗加8周CST；或2)常规医疗加8周注意力控制补充治疗。主要结果指标将包括：1)与头痛相关的生活质量，2)头痛频率，以及3)接受治疗的人所感受到的益处。第二个具体目标是确定与偏头痛的常规护理加辅助颅枕治疗相关的次要结果。数据收集将包括人口统计学、头痛强度和持续时间、健康状况、头痛相关残疾、医疗保健利用和药物使用。第三个具体目标是确定并找到解决方案，以进行更大规模的临床试验，以评估CST预防偏头痛的疗效。患者将从北卡罗来纳大学头痛诊所和当地的神经科诊所招募。每名受试者的研究时间为16周。整个项目的长度为2年。

DESCRIPTION (provided by applicant): Treatment of migraine continues to be a major health problem today, despite many new pharmacological therapies. Limited clinical experience suggests that craniosacral therapy (CST) may be effective in the treatment of headache, including migraine. The primary aim of this proposal is to gather quality preliminary data on the usefulness of CST as an adjunct to conventional care for patients with migraine and to determine the feasibility of a larger, randomized clinical trial of CST in patients with migraine. Craniosacral therapists use a technique of gentle palpation of the head, neck and spine to release restrictions in cranial and peri-spinal tissues that are believed to contribute to a variety of health problems including headache. It is estimated that more than 2 million visits to CST practitioners are made each year, with more than 10 per cent of those for the complaint of headache. There has been no rigorous research examining the usefulness of CST for patients with migraine despite the impression of beneficial effects. Our limited preliminary data show significant, sustained benefit of CST in a small group of patients with migraine. The First Specific Aim is to determine the feasibility of developing a clinical trial comparing craniosacral therapy versus low-strength static magnets (attention-control complementary therapy) as a treatment for preventing migraine headaches. Patients with migraine, with or without aura, under care of a neurologist will be studied. After an 8-week baseline period, they will be randomized to one of two groups: 1) usual medical care plus 8 weeks of CST; or 2) usual medical care plus 8 weeks of attention-control complementary treatment. Primary outcome measures will include: 1) headache-related quality of life, 2) headache frequency, and 3) perceived benefit in those receiving treatment. The Second Specific Aim is to identify relevant secondary outcomes associated with usual care plus adjunctive craniosacral therapy for migraine. Data collection will include demographics, headache intensity and duration, health status, headache-related disability, health care utilization, and medication use. The Third Specific Aim is to identify and find solutions for potential problems in conducting a larger clinical trial to assess the efficacy of CST for the prevention of migraine. Patients will be recruited from the University of North Carolina Headache Clinic and from local neurological practices. Duration of the study for each subject is 16 weeks. Length of the entire project is 2 years.